Sector Specific Regulations
Rules and guidance issued by U.S. agencies governing how AI is built and used in specific health domains.
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| Issuing Body | Regulation Name | Date Issued/Significantly Updated | Policy Type | Status | Sector | Link to Text |
|---|---|---|---|---|---|---|
| Food and Drug Administration | 2025-09-24 | Final Guidance | Final | Cross-cutting Healthcare | LINK | |
| Food and Drug Administration | 2025-09-12 | Notice | Issued | Cross-cutting Healthcare | LINK | |
| Federal Trade Commission | 2025-09-11 | Study | In Development | Cross-cutting AI policy | LINK | |
| National Institute of Standards and Technology | 2025-09-10 | Standards Pilot | Comments Open | Cross-cutting AI policy | LINK | |
| Centers for Medicare & Medicaid Services | 2025-08-04 | Final Rule | Final | Hospitals | LINK | |
| Centers for Medicare & Medicaid Services | 2025-04-15 | Final Rule | Final | Insurance | LINK | |
| Food and Drug Administration | 2025-01-07 | Draft Guidance | Draft | Medical Devices | LINK | |
| Food and Drug Administration | 2025-01-07 | Draft Guidance | Draft | Drugs & Biologics | LINK | |
| Department of Health and Human Services | 2024-12-17 | Final Rule | Final | Health IT | LINK | |
| Centers for Medicare & Medicaid Services | 2024-08-28 | Final Rule | Final | Hospitals | LINK | |
| Food and Drug Administration | 2024-08-22 | Draft Guidance | Draft | Medical Devices | LINK | |
| Federal Trade Commission | 2024-05-30 | Final Rule | Final | Health IT | LINK | |
| Centers for Medicare & Medicaid Services | 2024-05-06 | Final Rule | Final | Cross-cutting Healthcare | LINK | |
| Centers for Medicare & Medicaid Services | 2024-05-06 | Final Rule | Draft | Cross-cutting Healthcare | LINK | |
| Food and Drug Administration | 2024-05-06 | Final Rule | Final | Medical Devices | LINK | |
| Department of Health and Human Services | 2024-04-26 | Final Rule | Final | Privacy & Security | LINK | |
| Centers for Medicare & Medicaid Services | 2024-04-23 | Final Rule | Final | Insurance | LINK | |
| Department of Health and Human Services | 2024-03-18 | Guidance | Issued | Cross-cutting Healthcare | LINK | |
| Food and Drug Administration | 2024-03 | Final Guidance | Final | Medical Devices | LINK | |
| Food and Drug Administration | 2024-02-22 | Notice | Final | Cross-cutting Healthcare | LINK | |
| Department of Health and Human Services | 2024-02-16 | Final Rule | Final | Cross-cutting Healthcare | LINK | |
| Centers for Medicare & Medicaid Services | 2024-02-08 | Final Rule | Final | Health IT | LINK | |
| Department of Health and Human Services | 2024-02-08 | Final Rule | Final | Cross-cutting Healthcare | LINK | |
| Department of Health and Human Services | 2024-01-09 | Rulemaking Docket | Draft | Health IT | LINK | |
| Office of National Coordinator for Health IT | 2024-01-09 | Final Rule | Final | Health IT | LINK | |
| Centers for Medicare & Medicaid Services | 2023-11-22 | Final Rule | Final | Cross-cutting Healthcare | LINK | |
| Centers for Medicare & Medicaid Services | 2023-11-22 | Final Rule | Final | Cross-cutting Healthcare | LINK | |
| Centers for Medicare & Medicaid Services | 2023-11-16 | Final Rule | Final | Cross-cutting AI policy | LINK | |
| National Institutes of Health | 2023-06-23 | Policy Notice | Issued | Research | LINK | |
| Food and Drug Administration | 2023-05-10 | Discussion Paper | In Development | Cross-cutting AI policy | LINK | |
| Food and Drug Administration | 2023-01-03 | Docket | Draft | Medical Devices | LINK | |
| Centers for Medicare & Medicaid Services | 2022-11-23 | Final Rule | Final | Cross-cutting Healthcare | LINK | |
| Centers for Medicare & Medicaid Services | 2022-11-18 | Final Rule | Final | Cross-cutting AI policy | LINK | |
| Centers for Medicare & Medicaid Services | 2021-11-16 | Final Rule | Final | Cross-cutting Healthcare | LINK | |
| Centers for Medicare & Medicaid Services | 2021-11-16 | Final Rule | Final | Cross-cutting Healthcare | LINK | |
| Centers for Medicare & Medicaid Services | 2021-08-13 | Final Rule | Final | Hospitals | LINK | |
| Food and Drug Administration | 2021-01-12 | Program/Framework | Final | Cross-cutting AI policy | LINK | |
| Food and Drug Administration | 2021-01-12 | Action Plan | Issued | Medical Devices | LINK | |
| Centers for Medicare & Medicaid Services | 2020-12-29 | Final Rule | Final | Cross-cutting Healthcare | LINK | |
| Centers for Medicare & Medicaid Services | 2020-12-28 | Final Rule | Final | Cross-cutting AI policy | LINK | |
| Department of Health and Human Services | 2020-12-02 | Final Rule | Final | Cross-cutting Healthcare | LINK | |
| Centers for Medicare & Medicaid Services | 2018-11-23 | Final Rule | Final | Cross-cutting Healthcare | LINK | |
| Centers for Medicare & Medicaid Services | 2016-11-15 | Final Rule | Final | Cross-cutting Healthcare | LINK |